FDA Releases Draft Guidance For Risks Included On Medicine Advertisements

The Wall Street Journal (2/6, Silverman, 5.67M) blog “Pharmalot” is reporting that the FDA has issued new draft guidance requesting that drugmakers refrain from including long lists of risks and concerns associated with drugs in favor of a mild summary in print ads and promotional materials. The summary would not have to include information about all side-effect or contraindication. In the draft guidance, the agency explained that not many consumers have the technical background needed to understand some of the information described in the warnings as they exist now. The intention of the summary is to focus on the broader risks and important information instead of an exhaustive list of every possible issue.

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